The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination (FLU1)
11 de dezembro de 2018 atualizado por: Mark Mulligan, Emory University
This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.
Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine.
Immune system data will be collected at standard time points.
The duration of the study for each participant will be approximately 1 month.
Visão geral do estudo
Descrição detalhada
This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to evaluate differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.
Participants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. The duration of the study for each participant will be approximately 1 month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month follow-up period following vaccination.
The study has two primary objectives; to evaluate the antibody response to the influenza vaccine in people who are vaccinated regularly and those vaccinated less regularly; the second is to evaluate circulating follicular helper T cells (TFH) in people who are vaccinated regularly and those vaccinated less regularly.
Tipo de estudo
Intervencional
Inscrição (Real)
20
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- The Hope Clinic of the Emory Vaccine Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 30 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Capable of informed consent and provision of written informed consent before any study procedures.
- Capable of attending all study visits according to the study schedule.
- Are in good health, as determined by medical history and targeted physical exam related to this history.
- Oral temperature is less than 38 degrees Celsius.
- Resting pulse rate is between 50 and 115 beats per minute.
- Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination.
- Have received the influenza vaccine at least 3 of the past 5 years or have received the influenza vaccine in 2 or less of the past 5 years.
Exclusion Criteria:
- Have an acute illness within 72 hours before vaccination.
- Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of injury or confound the interpretation of the study results.
- Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
- Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
- Have known HIV, hepatitis B, or hepatitis C infection.
- Have a known history of autoimmune disease.
- Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
- Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
- Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
- Have planned vaccination with any vaccine during the 29-day duration of subject study participation.
- Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
- Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the 29-day duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.
- Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine.
- Have a history of severe reactions following vaccination with influenza virus vaccines
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Vaccination Naïve
Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
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Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
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Experimental: Vaccination Experienced
Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.
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Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer
Prazo: Baseline (Day 1), Day 29
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Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw.
Titer for serum HAI antibodies will be calculated using the geometric mean.
Change is defined as the difference in means from Day 1 to Day 29.
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Baseline (Day 1), Day 29
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Change in Mean Level of Circulating Follicular Helper T (TFH) Cells
Prazo: Up to 15 Days
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TFH cells will be collected via blood draw.
Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.
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Up to 15 Days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Mean Levels of Plasmablasts
Prazo: Up to 29 Days
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Plasmablasts will be collected via blood draw.
Change is defined as the difference in mean levels from baseline to Day 29.
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Up to 29 Days
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Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29
Prazo: Baseline (Day 1) and Day 29
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Memory B cells will be collected via blood draw.
Change is defined as the difference in mean levels from baseline to Day 29.
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Baseline (Day 1) and Day 29
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Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells
Prazo: Up to 29 Days
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Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw.
Change is defined as the difference in mean levels from baseline to Day 29.
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Up to 29 Days
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Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells
Prazo: Up to 29 Days
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CD8+T cells will be collected via blood draw.
Change is defined as the difference in mean levels from baseline to Day 29.
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Up to 29 Days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mark Mulligan, MD, Emory University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de julho de 2016
Conclusão Primária (Real)
18 de outubro de 2016
Conclusão do estudo (Real)
1 de dezembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
4 de agosto de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de agosto de 2016
Primeira postagem (Estimativa)
23 de agosto de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de dezembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de dezembro de 2018
Última verificação
1 de dezembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00090196
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